Innovative Surgical Solutions, LLC

Neuralytix, LLC

Depuy Synthes Products, Inc.

Christopher Wybo

Stephen Bartol

David S Nay

Aashish Shah

Darren Scarfe

Samantha J O'Neil

Lukas T Scarfe

Darren P Scarfe

Tarik Yardibi

Emir Osmanagic

Jacob A Marks

James G Lee

Gary Gordon

Aahish Shah

A method for assessing nerve health during a surgical procedure includes: applying one or more electrical stimuli proximate to the target nerve during the surgical procedure; detecting a muscle response evoked by the one or more electrical stimuli; determining at least one nerve function parameter indicative of the health or function of the target nerve; identifying a target range for the at least one nerve function parameter adapted for the target nerve, the target range being predictive of a desired nerve health status of the target nerve; and outputting an indication of the determined at least one nerve function parameter relative to the identified target range to provide real-time feedback during the surgical procedure involving the target nerve.

System and method for nerve health assessment

A method for refining a nerve health assessment model used during surgical procedures, includes accessing a database storing historical patient data; analyzing the historical patient data to generate or update a predictive model configured to estimate at least one of: a predicted post-operative outcome, an individualized target range for an intraoperative nerve function parameter, or a statistical risk profile for surgical complications; obtaining current intraoperative nerve function measurements; receiving actual post-operative outcome data for the current patient; updating the database to include new patient data associated with the current patient; and refining the predictive model based at least in part on the new patient data added to the database.

System and method for refining nerve health assessment models

A neuromuscular sensing method includes transmitting an electrical stimulus from a distal end portion of an elongate stimulator extending within an intracorporeal treatment area of a subject and detecting an artificially induced response of at least two muscles of the subject in response to the transmitted electrical stimulus, each response being detected by a respective sensor in mechanical communication with the muscle. A graphical user interface (GUI) is transitioned from a first state to a second state; the first state indicating to the transmission of a stimulus with no artificially induced response detected, and the second state indicating the detection of the artificially induced response of the at least two muscles, and further identifying one of the at least two muscles as a primary muscle response.

Intraoperative neural monitoring system and method

A method for intraoperative neural monitoring during a spinal decompression procedure, performed by a system comprising a processor, includes: generating an electrical stimulus with a controlled electrical current; transmitting the stimulus to an electrode contacting a nerve of a subject; receiving a mechanomyography (MMG) output signal from a mechanical sensor contacting a muscle innervated by the nerve; determining a nerve function parameter; and displaying the determined nerve function parameter relative to an identified target current range or statistical profile.

System and method for assessing nerve health during a spinal decompression procedure

A method for assessing nerve health during a spinal decompression procedure includes: transmitting electrical stimuli to a nerve; detecting muscle responses evoked by the stimuli; determining multiple nerve function parameters based on the responses; calculating a nerve function index based on a weighted combination of the parameters; storing the index in memory; and displaying the index. The nerve function parameters include at least two of: minimum stimulation threshold, maximal stimulation threshold, and magnitude of maximal muscle response.

System and method for assessing nerve health during a spinal decompression procedure using a calculated nerve function index

A method for assessing nerve health during a spinal decompression procedure includes: accessing a database containing historical patient data; receiving patient data of a target patient; identifying a subset of historical patients with similar pre-operative characteristics; generating an individualized target range for at least one nerve function parameter based on the subset; measuring an actual nerve function parameter of the target patient during the procedure; and displaying a graphical representation of the measured parameter relative to the individualized target range.

System and method for empirical assessment of nerve health during a spinal decompression procedure

A nerve mapping system includes an elongate medical device, a non-invasive mechanical sensor, and a processor. The elongate medical device includes a distal end portion configured to explore an intracorporeal treatment area of a subject, and the distal end portion includes an electrode. The non-invasive mechanical sensor is configured to provide a mechanomyography output signal corresponding to a monitored mechanical response of a muscle innervated by the nerve. The processor is in communication with the electrode and the sensor, and is configured to provide a plurality of electrical stimuli to the electrode. Each of the plurality of stimuli is provided when the electrode is located at a different position within the intracorporeal treatment area. The processor determines the likelihood of a nerve existing at a particular point using the magnitudes of each of the stimuli and the detected response of the muscle.

Neural locating system and method

A sensing device for detecting an artificially induced neuromuscular response within a limb of a subject includes a carrier material and a plurality of mechanical sensors. The carrier material is operative to be secured around a portion of the limb, and each of the plurality of mechanical sensors are coupled with the carrier material. Each mechanical sensor is positioned on the carrier material such that it is operative to monitor a mechanical response of a different muscle group of the limb. Each mechanical sensor then generates a respective mechanomyography output signal corresponding to the monitored mechanical response of its adjacent muscle group.

Neuromuscular sensing device with multi-sensor array

A method for detecting an artificially induced neuromuscular response in a subject includes receiving a mechanomyography (MMG) output signal from a mechanical sensor in contact with a muscle of the subject; applying one or more conditioning filters to the MMG output signal to generate a conditioned signal and analyzing the conditioned signal to identify one or more candidate waveforms. Each candidate waveform meets one or more analog or digital signal characteristic criteria associated with an artificially induced neuromuscular response. The method then compares a first candidate waveform to a second candidate waveform to determine a degree of similarity between the first and second candidate waveforms, and provides an alert to a user that indicates detection of the artificially induced neuromuscular response when the degree of similarity exceeds a predetermined threshold.

Intraoperative neural monitoring method

An intraoperative neural monitoring system for use during a surgical procedure on a subject includes a mechanical sensor and a processor. The mechanical sensor is configured to monitor a physical motion of a muscle of the subject and provide a mechanomyography (MMG) signal corresponding to the monitored physical motion. The processor is configured to receive the MMG signal, apply a wavelet transform to the MMG signal, and determine, from the output of the wavelet transform, if the monitored physical motion of the muscle is an artificially induced neuromuscular response that is attributable to an applied electrical stimulus. If the processor determines that the monitored physical motion of the muscle is an artificially induced neuromuscular response, it then provides an indication to a user.

Intraoperative neural monitoring system utilizing wavelet-based event detection

A method of alerting a user to an artificially induced neuromuscular response in a subject includes generating a mechanomyography (MMG) output signal corresponding to a mechanical motion of a muscle of a subject, applying a wavelet transform to the MMG output signal to determine a convolution coefficient for each of a plurality of daughter wavelets, summing the convolution coefficients determined across the plurality of daughter wavelets at each timestep across a plurality of timesteps to generate a net-convolution coefficient (NCC), identifying one or more peaks in the NCC via a peak finding algorithm, and alerting a user of an artificially induced neuromuscular response following the identification of one or more peaks in the NCC. Each daughter wavelet of the plurality of daughter wavelets is a time-scaled variant of a common mother wavelet, and the convolution coefficient is indicative of a similarity between the daughter wavelet and the MMG output signal.

Intraoperative neural monitoring method utilizing wavelet-based event detection

A method of alerting a user to the existence of an artificially induced neuromuscular response in a subject includes: generating a series of electrical stimuli at a predetermined period with an electrode disposed at a distal end portion of an elongate medical device; detecting a series of mechanomyographic (MMG) responses of the subject using a mechanical sensor, each MMG response indicative of a contraction of a muscle of the subject; determining a degree of statistical confidence that the detected series of MMG responses was artificially induced by the series of electrical stimuli; and outputting, to the user, both an alert that a series of MMG responses has been detected, and the determined degree of statistical confidence that the detected series of MMG responses was artificially induced by the series of electrical stimuli.

Intraoperative neural monitoring method with statistical confidence determination

Neural locating system

A neural monitoring system for detecting an artificially-induced mechanical muscle response to a stimulus provided within an intracorporeal treatment area includes a mechanical sensor, a stimulator, and a processor. The processor is configured to provide a periodic stimulus via the stimulator, and monitor the output from the mechanical sensor in an expected response window that follows one stimulus, yet concludes before the application of the next, subsequent stimulus to determine if the stimulus induced a response of the muscle.

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Highland, MI, United States of America

Christopher Wybo